Urinary Incontinence, StressUROSEPNCT03332654
Stress Urinary Incontinence in Women With Multiple Sclerosis
An observational study of Urinary Incontinence, Stress and Multiple Sclerosis, run by Lille Catholic University.
Trial summary
Objective: To report the prevalence and risk factors of stress urinary incontinence (SUI) and the prevalence of intrinsic sphincter deficiency in women with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress, Multiple Sclerosis
- What is being tested?
- Determine prevalence of stress urinary incontinence
- How many people
- 363 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 31 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women aged >18 years with multiple sclerosis, who had undergone a urodynamic test for lower urinary tract symptoms were included
Who may be able to join
- Women aged >18 years
- Multiple sclerosis
- Urodynamic test for lower urinary tract symptoms
- Followed in Saint Philibert Hospital between December 1999 to June 2014
Who cannot join
- Non confirmation of diagnosis of Multiple sclerosis
About this study
Official title: Prevalence and Risk Factors of Stress Urinary Incontinence in Women With Multiple Sclerosis
Objective: To report the prevalence and risk factors of stress urinary incontinence (SUI) and the prevalence of intrinsic sphincter deficiency in women with multiple sclerosis (MS). Methods: A retrospective study was conducted among Female patients with MS, followed for lower urinary tract symptoms (LUTS) during a 15-year period. Demographic data, MS history, expanded disability status scale (EDSS) score at the urodynamic visit, obstetrical past, birth weight, LUTS, and urodynamic findings were collected. SUI was defined as incontinence during cough, or any effort. A maximum urethral closure pressure less than 30 cm H2O defined intrinsic sphincter deficiency. Results: In total 363 women with a mean age of 46.7±10.8 years and a mean disease duration of 12.9±8.7 years were included. The incidence of relapsing remitting MS, a secondary progressive form, and a primary progressive form was 60.6%, 32.8%, and 6.6%, respectively. The prevalence of SUI was 31.4%. The prevalence of intrinsic sphincter deficiency was 1.4% and 0.8% of these patients had a SUI (P=0.300). In a multivariate analysis, women with a SUI had significantly higher birth weight (P=0.030), a pelvic organ prolapse (P=0.021), urgent urinary incontinence (P=0.006), a lower EDSS score (P=0.019), and a weaker containing effort (P<0.001). Conclusions: The prevalence of SUI in women with MS was 31.4%. This symptom could affect the quality of life of women with MS.
- Conditions
- Urinary Incontinence, Stress, Multiple Sclerosis
- Being tested
- Determine prevalence of stress urinary incontinence
- Keywords
- Urinary Incontinence, Stress, Multiple Sclerosis, Lower Urinary Tract Symptoms
- Medical subject headings
- Urinary Incontinence, Stress, Multiple Sclerosis, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determine prevalence of stress urinary incontinenceOther
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | Prevalence and risk factor of stress urinary incontinence in women with multiple sclerosis and included in the database over 15 years from December 1999 to June 2014, who had undergone a urodynamic test Receives: Other: Determine prevalence of stress urinary incontinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress urinary incontinence
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Feb 2015
- Primary completion31 Jan 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecile Donzé, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332654
- Sponsor's protocol ID
- OBS-019
- Acronym
- UROSEP
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Stress Urinary Incontinence in Women With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03332654
- Acronym / sponsor ID
- UROSEP / OBS-019
- Conditions
- Urinary Incontinence, Stress, Multiple Sclerosis
- Keywords
- Urinary Incontinence, Stress, Multiple Sclerosis, Lower Urinary Tract Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To report the prevalence and risk factors of stress urinary incontinence (SUI) and the prevalence of intrinsic sphincter deficiency in women with multiple sclerosis (MS). Methods: A retrospective study was conducted among Female patients with MS, followed for lower urinary tract symptoms (LUTS) during a 15-year period. Demographic data, MS history, expanded disability status scale (EDSS) score at the urodynamic visit, obstetrical past, birth weight, LUTS, and urodynamic findings were collected. SUI was defined as incontinence during cough, or any effort. A maximum urethral closure pressure less than 30 cm H2O defined intrinsic sphincter deficiency. Results: In total 363 women with a mean age of 46.7±10.8 years and a mean disease duration of 12.9±8.7 years were included. The incidence of relapsing remitting MS, a secondary progressive form, and a primary progressive form was 60.6%, 32.8%, and 6.6%, respectively. The prevalence of SUI was 31.4%. The prevalence of intrinsic sphincter deficiency was 1.4% and 0.8% of these patients had a SUI (P=0.300). In a multivariate analysis, women with a SUI had significantly higher birth weight (P=0.030), a pelvic organ prolapse (P=0.021), urgent urinary incontinence (P=0.006), a lower EDSS score (P=0.019), and a weaker containing effort (P<0.001). Conclusions: The prevalence of SUI in women with MS was 31.4%. This symptom could affect the quality of life of women with MS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | – | Other: Determine prevalence of stress urinary incontinencePrevalence and risk factor of stress urinary incontinence in women with multiple sclerosis and included in the database over 15 years from December 1999 to June 2014, who had undergone a urodynamic test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women aged >18 years with multiple sclerosis, who had undergone a urodynamic test for lower urinary tract symptoms were included
Key inclusion criteria (4 listed)
- Women aged >18 years
- Multiple sclerosis
- Urodynamic test for lower urinary tract symptoms
- Followed in Saint Philibert Hospital between December 1999 to June 2014
Key exclusion criteria (1 listed)
- Non confirmation of diagnosis of Multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determine prevalence of stress urinary incontinence | Other | Multiple sclerosis |
Primary outcome
Stress urinary incontinence
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecile Donzé, MD principal investigator
GHICL
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, Stress and Multiple Sclerosis, run by Lille Catholic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress urinary incontinence (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.